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comparing the effectiveness of the Ringer lactate vs.mixture of hypertonic saline and Ringer lactate , on hemodynamic variables in major uro-oncologist surgeries

Protocol summary

Study aim
The intraoperative hemodynamic and metabolic effects of two fluid regimens in major Uro-Oncologic surgeries.
Design
Two arm 27 patients, parallel group, randomized trial with double blinded perioperative fluid management assessment
Settings and conduct
This study will done in Urologic operating room on two separated group. In control group they receive ringer lactate for perioperative fluid management and in case group, they take a mixture of ringer lactate and hypertonic saline. the patient and anesthetic nurse who will infuse the fluid would not inform the type of groups.
Participants/Inclusion and exclusion criteria
. Inclusion criteria: patients with ASA≤ III who were scheduled for major Uro-Oncologic surgeries. Exclusion criteria: GFR<45 ml/min.
Intervention groups
Control group: Intra operative fluid management with Ringer lactate Case group: Intra operative fluid management with the mixture of ringer lactate and hypertonic saline
Main outcome variables
Hemodynamic conditions; Electrolytes; Arterial Blood Gas;

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150116020676N3
Registration date: 2019-01-10, 1397/10/20
Registration timing: prospective

Last update: 2019-01-10, 1397/10/20
Update count: 0
Registration date
2019-01-10, 1397/10/20
Registrant information
Name
Farhad Tavakoli
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2226 9950
Email address
ftavakoli@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-07-23, 1398/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparing the effectiveness of the Ringer lactate vs.mixture of hypertonic saline and Ringer lactate , on hemodynamic variables in major uro-oncologist surgeries
Public title
The effect of hypertonic saline in intraoperative fluid management
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
all patients with ASApsI-III who scheduled for major Uro-Oncologic surgeries
Exclusion criteria:
GFR<45 ASAps >3 patients refusal
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Data analyser
Sample size
Target sample size: 54
Randomization (investigator's opinion)
Randomized
Randomization description
According random 4 BLOCK that will make by excel software .
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patient how entered this study would not inform about the type of fluid management. The anesthetic nurse don't have information about the fluid using for fluid management during the study
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Imam Khomeini Hospital, Keshavariz Blvd.
City
Tehran
Province
Tehran
Postal code
14197-33141
Approval date
2017-10-16, 1396/07/24
Ethics committee reference number
IR.TUMS.IKHC.REC.1396.3724

Health conditions studied

1

Description of health condition studied
Intraoperative Fluid management
ICD-10 code
E87
ICD-10 code description
Other disorders of fluid, electrolyte and acid-base balance

Primary outcomes

1

Description
Mean Arterial Pressure, Central Vein Pressure
Timepoint
Mean arterial pressure and central vein pressure were evaluated during surgery continuously.
Method of measurement
Digital Blood Pressure Monitor

Secondary outcomes

1

Description
Electrolytes, Arterial blood Gas
Timepoint
Hourly
Method of measurement
Nova plus-M,U.S.A lab kits

Intervention groups

1

Description
Intervention group: In this group, the mixture of hypertonic saline and ringer lactate will use for intraoperative fluid management.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Complex Hospital Urology Operating Room
Full name of responsible person
Hosein Gholami
Street address
Imam Khomeini Hospital, Keshavariz Blvd.
City
Tehran
Province
Tehran
Postal code
14197-33141
Phone
+98 21 6119 2828
Email
Dr.ghlami65@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhond zadeh M.D
Street address
Imam Khomeini Hospital, Keshavariz Blvd.
City
Tehran
Province
Tehran
Postal code
14197-33141
Phone
+98 21 6119 2828
Email
Dr.ghlami65@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
HamidReza Amiri
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini Hospital, Keshavariz Blvd.
City
Tehran
Province
Tehran
Postal code
14197-33141
Phone
+98 21 6119 2828
Email
hr.amiri@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hosein Gholami
Position
Anesthetics Residence
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini Hospital, Keshavariz Blvd.
City
Tehran
Province
Tehran
Postal code
14197-33141
Phone
+98 21 6119 2828
Email
Dr.ghlami65@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hosein Gholami
Position
Anesthetics Residence
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini Hospital, Keshavariz Blvd.
City
Tehran
Province
Tehran
Postal code
14197-33141
Phone
+98 21 6119 2828
Email
Dr.ghlami65@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Nameless of patients data will be demonstrate, when this study got completed
When the data will become available and for how long
Access to these data will allowable 3 month after publishing.
To whom data/document is available
It is only accessible for academic and scientific organs.
Under which criteria data/document could be used
Analysis of these data are allowable
From where data/document is obtainable
Hosein gholami M.D Dr.ghlami65@gmail.com 00982161192828
What processes are involved for a request to access data/document
In one month data will accessible.
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